Back to resultsA Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients. (SMART)
Primary Purpose
Bone Loss
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Pamidronate
Sponsored by
About this trial
This is an interventional treatment trial for Bone Loss focused on measuring Renal, transplant,, pamidronate,, ciclosporin,, Ciclosporin A,, steroids,, bone mineral density,, fracture rates, immunosuppressive, regimen
Eligibility Criteria
Inclusion Criteria:
- First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
- De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
Exclusion Criteria:
- Previous or current bone disease unrelated to end stage renal failure.
- Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
- Treatment at any time with a bisphosphonate.
- d. Calcitonin treatment during the previous month.
- Malignancy (current or history within last 5 years)
- Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.
Protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Parmidronate
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00738257
Brief Title
A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.
Acronym
SMART
Official Title
A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
Keywords
Renal, transplant,, pamidronate,, ciclosporin,, Ciclosporin A,, steroids,, bone mineral density,, fracture rates, immunosuppressive, regimen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parmidronate
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pamidronate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
Exclusion Criteria:
Previous or current bone disease unrelated to end stage renal failure.
Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
Treatment at any time with a bisphosphonate.
d. Calcitonin treatment during the previous month.
Malignancy (current or history within last 5 years)
Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.
Protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cunningham, MD
Organizational Affiliation
Royal London Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Frimley
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19393473
Citation
Walsh SB, Altmann P, Pattison J, Wilkie M, Yaqoob MM, Dudley C, Cockwell P, Sweny P, Banks LM, Hall-Craggs M, Noonan K, Andrews C, Cunningham J. Effect of pamidronate on bone loss after kidney transplantation: a randomized trial. Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.
Results Reference
derived
Learn more about this trial
A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.
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